
Regulatory compliance is critical to achieving success in the pharmaceutical industry. We offer a professional and flexible approach to conducting your GMP audit, from scheduling and planning, to ensuring all follow up activities have been closed out. Contact us for more information.
Having worked in the pharmaceutical industry for more than 20 years, Lisa is a GMP expert with extensive knowledge of QC testing, analytical method validation, solid oral dose manufacturing, and packaging. Lisa has audited CMOs in the UK, EU and USA. She is IRCA registered and a member of the CQI. Certificates, CV and her audit bio can be provided upon request.
We can carry out impartial and independent vendor qualification, routine and for-cause GMP audits globally. We can also support you with GMP gap analysis and inspection readiness programs.
We will work closely with you to ensure that the audit aligns with your requirements and covers all relevant GMP activities. Up front planning and document review will be undertaken to support an efficient on-site audit. A full report with categorized outcomes will be provided post-audit. Follow up activities including reviewing responses, CAPA plans and close outs can also be provided, giving you a complete GMP audit package.